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Pregnancy: There are no adequate and well-controlled studies of mesalazine in pregnant women. Mesalazine is known to cross the placental barrier.
Congenital malformations and other adverse outcomes (including one event of hydrops fetalis and fetal anaemia in one infant) were reported in infants born to mothers who were exposed to mesalazine during pregnancy. Mezavant should be only used during pregnancy if the benefits outweigh the risks.
Breast-feeding: Mesalazine is excreted in breast milk at low concentration. Acetylated form of mesalazine is excreted in breast milk at higher concentration. Caution should be exercised if using Mesalazine while breast-feeding and only if the benefit outweighs the risks. Sporadically acute diarrhoea has been reported in breast fed infants.
Fertility: Data on mesalazine show no sustained effect on male fertility.
